What can be done to ensure that consumers are not exposed to dietary supplements that are unsafe? The Dietary Supplement Health and Education Act of 1994 (DSHEA)6 posits that dietary supplements are “presumed safe” until proven to be otherwise. Clearly, the body of evidence accumulated since 1994 indicates that this assumption is no longer in the public interest and needs to be revised. What needs to happen? First, we need to determine what we mean by “safe.” All things have potential risks: excess salt intake is associated with hypertension, water is necessary for life yet too much water intake can cause dangerous hyponatremia, and too much oxygen can cause various lung and eye conditions. So “safe” cannot equal “no risk at all.” How much risk is too much? This is where the “benefit” comes into play. As a primary care physician, I commonly prescribe pharmaceuticals that I know to have risks, sometimes serious risks, but I do so when the evidence supports that the expected benefit (such as the mortality reduction in patients with systolic heart failure treated with angiotensin-converting enzyme inhibitors) exceeds the expected risks (eg, angioedema, renal failure) by a sufficiently large margin indicating that the prescription is appropriate. What is the benefit of taking a dietary supplement? Under the DSHEA,6 dietary supplements cannot claim to treat medical conditions, meaning that Enzyte cannot claim to treat erectile dysfunction. Rather, dietary supplements may only make “structure/function” claims, ergo, Enzyte promotes “male enhancement.” This distinction is probably lost on many if not most consumers. Furthermore, even to promote “male enhancement” implies a biologically active mechanism for the ingredients in Enzyte. I believe that if a biologically active effect is stated, then there needs to be evidence that this is indeed the case. Disturbingly, in many recent rigorous trials of dietary supplements, they have been found to be no more effective than placebo.7- 10 We are left, then, in the situation where evidence of benefit is slim to nonexistent, which then makes any level of risk—even if it is simply a signal and not evidence of the risk itself, as in the case of Enzyte—a sufficient concern to warrant a recommendation against using it.